System and method for immutable virtual pre-site study

ABSTRACT

Virtual site inspections to support clinical trials is disclosed. A frame and glasses subsystem has at least a global positioning system (GPS) and is associated with a first computing device at a physical site where an inspection is conducted. A session is opened in a web-based application on a second communication device that is in communication with, but that is physically remote from, the first computing device. Location tracking using GPS allows for a location of the frame and glasses subsystem to be continuously tracked. A script from the web-based application to the first computing device enables association with a video stream and locations within the physical site. The script enables responses to be provided from the first computing device at the locations. The locations, time stamps, video stream, the responses from the script, and a device identifier is provided immutably to the web-based application.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a U.S. National Phase under 35 U.S.C. § 371 ofInternational Application PCT/US2021/023711 filed on Mar. 23, 2021,which claims priority to U.S. Provisional Application No. 62/993,537,filed Mar. 23, 2020, titled SYSTEM AND METHOD FOR PRE-SITE STUDY VISITPROCEDURES FOR CLINICAL RESEARCH TRIALS, the entire disclosure of whichis incorporated by reference herein for all intents and purposes.

BACKGROUND 1. Field of Invention

This invention relates in general to clinical research trial systems andmethods, and in particular, to interfaces for such clinical researchtrial systems.

2. Description of the Prior Art

Clinical trials are part of clinical research and constitute the heartof medical advances. Clinical trials look at innovative methods toprevent, detect, or treat diseases. Treatments may include new drugs,new surgical procedures, new devices, or new ways to use existingtreatments. A goal achieved in such clinical trials is to ascertainwhether a new treatment works, is safe for administering, and haspotential to improve the quality of life for people with illnessesaddressable by such new treatment.

Clinical trials that support Federal Drug Administration (FDA) approvalsfor new drugs involve substantial costs. Such cost can extend evenfurther for certain drug development processes. Pharmaceutical companiesin the United States include costs of critical clinical trials in itsprocesses for FDA approvals of new drugs. Inclusion of costs fromcritical clinical trials adds to a final high cost associated with drugdevelopment, because it also includes costs associated with the drugdevelopment activity itself. Furthermore, studies, including those fordrug discovery, can be time-consuming and can range from 6 months to 10years.

Pharmaceutical companies may contract with research sites, such as,doctors' offices and hospitals to conduct such clinical trials. However,before expending money and time to conduct such trials, pharmaceuticalcompanies ensure that a research site is sufficient to undertake demandsassociated with such trials. To ensure sufficiency of one or moreresearch sites, a Clinical Research Associate (CRA) conducts a pre-sitestudy visit (PSSV), which can include a tour of the research site,interviews with a study coordinator and physician, and other items thatmay be defined by a checklist. Such a checklist is required to becompleted to conclude a pre-site study visit. Other items for achecklist may also include verification (and inventory) of equipment ateach research site, temperature logs at the research site, and any andall standard operating procedures (SOPs) in place.

A Pre-Selection Site Visit (PSSV) can take between two to four hours ateach research site. Such time may not include travel and preparationrequired by a CRA. With a traditional model for PSSV, it can take, onaverage, between six to eight months for clinical trials to commence.About an initial 3-month portion of such time may be dedicated to aPSSV. With a shortage of CRAs and with multiple projects havingdifferent target dates, research sites may not have key questionsanswered to enable determination of whether they can successfully enrolla clinical trial. Furthermore, CRAs may have to travel to the sites andhave to schedule a PSSV in accordance with schedules of physicians,study coordinators, and all other key players who must attend an PSSV,and who may not be able to do so. Still further, informationcommunicated between parties during a PSSV are disconnected ordiscretized pieces of data without features for association atinspection points of a research site, without underlying features toprovide evidentiary support that specific inspection was actuallyperformed, and without features that dissuades change to such pieces ofinformation or that maintains confidentiality.

SUMMARY

At least one embodiment described below addresses issues raised in theabove sections to enable immutable virtual pre-site study while keepinginformation communicated between parties during a PSSV properlycoordinated to each inspection point at a research site and retainedwith immutability and confidentiality.

In at least one embodiment, a system for immutable virtual pre-sitestudy to support clinical trials is disclosed. Such a system includes aframe and glasses subsystem that may further include at least a globalpositioning system (GPS) and a camera and may include at least oneprocessor and memory having instructions that when executed by the atleast one processor cause the system to perform certain functions oractions. A function caused includes opening of a session in a web-basedapplication for the system. In at least one embodiment, such a sessionmay be associated with an immutable virtual pre-site study, which mayrepresent an immutable virtual PSSV. The immutable virtual pre-sitestudy may be conducted using a first computing device linked to thesession and that may be associated with the frame and glasses subsystem,at a physical location of an immutable virtual PSSV. Location tracking,using the GPS, may be enabled for a location of the frame and glassessubsystem during the immutable virtual pre-site study. Transmission of ascript is enabled from the web-based application to the first computingdevice, which is remote from a second computing device interfacing withthe web-based application. Such a script may be associated with a videostream from the camera and with a location of the frame and glassessubsystem. Display of such a script is enabled along with the videostream for a first computing device using GPS tracking of the videostream and target insertion points within the script, so as to enablequestions at certain locations of a pre-site visit and to enableresponses from the first computing device Immutable association isenabled of two or more of locations, time stamps, the video stream, theresponses to the script, and a device identifier, in the first computingdevice.

In at least one embodiment, a method for method for immutable virtualpre-site study to support clinical trials is also disclosed. Such amethod is enabled in a system provided with a frame and glassessubsystem in association with at least a global positioning system (GPS)and a camera. The method includes opening a session in a web-basedapplication, where the session may be associated with an immutablevirtual pre-site study using a first computing device that is linked tothe session and that is associated with the frame and glasses subsystem.Location tracking is enabled in the method, using the GPS, for alocation of the frame and glasses subsystem during the immutable virtualpre-site study. Transmission is enabled for a script, from the web-basedapplication to the first computing device that is remote from a secondcomputing device interfacing with the web-based application. The scriptmay be associated with a video stream from the camera and with thelocation. The script is displayed with the video stream for the firstcomputing device and enables generation of responses from the firstcomputing device Immutable association is enabled of two or more oflocations, time stamps, the video stream, the responses to the script,or a device identifier, in the first computing device.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments in accordance with the present disclosure will bedescribed with reference to the drawings, in which:

FIG. 1 illustrates a computer system configured for use with at leastone embodiment herein;

FIG. 2 illustrates further details of a computer system configured foruse with at least one embodiment, that is subject to improvements of atleast one embodiment herein;

FIG. 3 illustrates aspects of a system for an immutable virtual pre-sitestudy according to at least one embodiment herein;

FIG. 4 illustrates aspects of a method for an immutable virtual pre-sitestudy according to at least one embodiment herein;

FIG. 5 illustrates other aspects of a method for an immutable virtualpre-site study according to at least one embodiment herein;

FIG. 6 illustrates a frame and glasses subsystem for an immutablevirtual pre-site study according to at least one embodiment herein;

FIG. 7 illustrates a communication aspects in a system for an immutablevirtual pre-site study according to at least one embodiment herein;

FIGS. 8-12 illustrate user interface aspects for an immutable virtualpre-site study according to at least one embodiment herein;

FIGS. 13A, 13B, 13C illustrates a form aspects for a script to beassociated with at least a video stream in a system for an immutablevirtual pre-site study according to at least one embodiment herein;

FIG. 14 illustrates a hardware aspects in a system for an immutablevirtual pre-site study according to at least one embodiment herein; and

FIG. 15 illustrates a method for an immutable virtual pre-site studyaccording to at least one embodiment herein.

DETAILED DESCRIPTION

In the following description, various embodiments will be described. Forpurposes of explanation, specific configurations and details are setforth in order to provide a thorough understanding of the embodiments.However, it will also be apparent to one skilled in the art that theembodiments may be practiced without the specific details. Furthermore,well-known features may be omitted or simplified in order not to obscurethe embodiment being described.

Various other functions can be implemented within the variousembodiments as well as discussed and suggested elsewhere herein. In atleast an aspect, the present disclosure is to a system and a method forimmutable virtual pre-site study.

In at least one embodiment, system features (such as hardware) alongwith software (either as an application or firmware) enable or allowreal-time exchange and storage of an immutable virtual PSSV information.Such exchange may include immutable association of two or more pieces ofinformation provided to a first computing device at a physical site,such as a research site associated with an immutable virtual PSSV. Allinformation related to a physical site required for an immutable virtualPSSV may be exchanged between at least the first computing device, aframe and glasses subsystem, and a web-based application interfacingwith a second computing device that may be remote from the firstcomputing device and from the frame and glasses subsystem.

A system that tracks and records discrete data may be unable to provideverification across the different data (and associated data types, suchas video, audio, location, and text scripts), except that they areindependently gathered and independently interfaced to and from a userof such a system. In at least one embodiment, a system and method hereinmay associate discrete pieces of information from different sourcesusing, for example, time stamps and GPS -tracked location, during a sitevisit, and target insertion points in a script having the questions.Such a feature also enables a script to be associated with a videostream, in real-time, during a pre-site visit using GPS locations andenables responses at certain time stamps, all of which are immutablystored. In at least one embodiment, such an association is beneficial ina specific application of discretized data for pre-site visits, wherespecific discretized data (video stream, location, questions, andresponses) is rigorously verified, associated, and stored in animmutable manner

The system and method may support verification requirements for pre-sitevisits in real-time, such that questions intended for certain inspectionactions (for example, at certain locations at a research site) may bepresented for responses, and their responses received for immutablestorage in an associated manner with the questions, locations, and timestamps. A verification requirement for a pre-site visit may includeassociation between a location determined via GPS of specific equipmentin a research site that is determined as related to a target insertionpoint stated in a script having the questions. Such association may bean immutable association between discrete data by location tags (such astarget insertion points and/or GPS data), time stamps (at such alocation associated to the data), and read-only storage of such data.The system and method may further include an ability to receive a scriptand associate such a script to a video stream in real time, along withsecuring responses to questions within a script at locations during apre-site visit, providing benefits over purely discrete data otherwisereceived.

The system and method also enable appropriate questions (such asrelating to a specific equipment or area in a research site) to bedisplayed on a first computing device in coordination with a frames andglasses subsystem. As a study monitor or CRA is located remotely from asite coordinator, such a feature addresses an inability of a CRA orstudy monitor to physically track a study coordinator, but to stillsecure a verified and fully answered pre-site visit. Thus, verificationthat the specific equipment was inspected during the pre-site visit canbe obtained.

The frame and glasses subsystem used in the inspection system and methoddisclosed herein may be in near-field proximity communication with thefirst computing device that then communicates with the web-basedapplication of a remote second computing device. The system and methodherein is therefore able to track locations, time stamps, an audiostream, a video stream, responses to a script, and a device identifier,and is able to formalize this information for a web-based application.This at least reduces time and cost for newly formed entities to conducttheir an immutable virtual PSSVs virtually. Such an immutable virtualpre-site study includes providing a study coordinator (remote from aCRA) with smart glasses that form a frame and glasses subsystem and thatmay be associated with a camera. A system and method of an immutablevirtual pre-site study allows such a study coordinator to be embedded ata research site in advance of an immutable virtual PSSV, and thenenables immutable retrieval and use of information from a research site.

A study coordinator equipped with such a frame and glasses subsystem isable to move around a research site and is able be linked (via the firstcomputing device) with a session of a web-based application associatedwith a second computing device of a CRA. A first computing device at aresearch site may be in near-field proximity communication, usingBluetooth®, or even broader range but local communication such asWi-Fi®, with a frame and glasses subsystem. In turn, the first computingdevice may be linked to a web-based session opened using a web-basedapplication of a second computing device. This enables a secure portalbetween a study coordinator and a CRA located remotely from a studycoordinator. In at least one embodiment, this allows a web-basedapplication to host multiple distinct sessions to preventcross-contamination of data from different research sites.

The study coordinator, moving around with a frame and glasses subsystemis able to show a CRA, who is located off-site (or remotely from thestudy coordinator, all items on a script that may be provided to thefirst computing device. The script may include a pre-site checklist,such as to check a pharmaceutical refrigerator, temperature logs,centrifuge, exam room, and other aspects required for an immutablevirtual PSSV. The CRA can view any image or video stream in a similartime frame and view as a study coordinator. As the study coordinator islooking at certain views in real-time, an image (such as frames ofvides) of the views may be streamed to a CRA's computer screen (on asecond computing device). This enables a CRA to verify that a researchsite has sufficient equipment and space to conduct a research study.

Furthermore, such a process may require immutable association of two ormore pieces of information sent to a first computing device at aphysical site. Two or more of time stamps, scripts, responses, andlocations, or device identifiers may be required to be combined andlocked to prevent improper changes. Metadata, encryption, or distributedledgers may be used to enable immutable association of two or morepieces of such information. This enables credibility for the informationfrom an immutable virtual PSSV returned to web-based application andaccessible to a second computing device. The information may be furtherloaded to a cloud computing environment and the session itself may beopened on a cloud computing environment using virtual or physicalcomputing devices that may be transparent to users of the firstcomputing device and of the second computing device.

There may be circumstances where travel is impeded by a CRA, directly toa research site, but that approval of an underlying drug or device isimportant. In a recent example, the Center for Disease Control (CDC) inthe United States discouraged travel in order to deter spread of a virusduring a pandemic (such as spread of COVID-19). However, approval of avaccine for such a virus is also extremely important and time-sensitive.More so, in a pandemic, where time is crucial in the area of drugdevelopment, pharmaceutical companies have limited time and resources toexpend in aspects that are away from drug development. Such rationing oftime must be assisted by expedited and proper clearances, such asenabled by a system and method for an immutable virtual pre-site studyvisit procedure. In an example, CRAs may be sent to research cites, inperson, to review setups for clinical trials and to ensure credibilityof information, but this is a costly, time-consuming, and imperfectsolution that may also cost human lives, especially during a pandemic.

A PSSV physically conducted in person by a CRA can take about threemonths to complete and can be very expensive if considered for everypre-site visit. However, the system and method for an immutable virtualpre-site study described herein is able to support remote sessions andimmutable association, transmission, and storage of data so that around75 immutable virtual PSSVs may be completed in two weeks. Thus,conducting site visits and inspections using the system and methoddescribed herein maintains credibility of information gathered whilereducing costs that would otherwise be incurred to send a CRA to aplurality of sites to conduct physical, in-person inspections. Thesystem and method for an immutable virtual pre-site study allowspharmaceutical companies to allocate costs to other crucial areas ofdrug development. In addition, the system and method can savepharmaceutical companies time required for conducting the PSSVs. Stillfurther, once credibility of information is achieved, drugs or treatmentplans may be approved in a timelier manner.

A CRA may be a health-care professional who performs many activitiesrelated to medical research, particularly clinical trials. Further, CRAswork in various settings, such as pharmaceutical companies, medicalresearch institutes, and government agencies. A Pre-Site Study Visit oran immutable virtual PSSV refers to a requirement that, before a sponsorawards a clinical trial to a site, a sponsor (such as a CRA) conduct apre-site study visit. An immutable virtual PSSV may be designed to helpsponsors select qualified investigators and to help determine a researchsite's ability to conduct a clinical trial. To be selected, studycoordinators may first be qualified by training and by education andexperience. Moreover, a research site must have adequate resources,staffing, and facilities that may be necessary to conduct a study asproposed.

A study coordinator is in reference to a person who coordinates animmutable virtual PSSV with other participants at the site and a remoteCRA during a session on a web-based application, such as a virtual sitemonitoring application (or a virtual immutable virtual PSSVapplication). A virtual site monitoring application may be a stand-aloneor browser-based mobile or computer-application that may be configuredto be part of a system and method for an immutable virtual pre-sitestudy. Participants or other participants referred to herein may includeCRAs, physicians, study coordinators, or other individuals and entitiesgiven access to one or more session(s) of a web-based application (suchas an immutable virtual PSSV session in the virtual site monitoringapplication) or and that may be involved in a clinical research trial.

FIG. 1 illustrates an example environment 100 subject to improvements ofat least one embodiment herein. As shown in FIG. 1 , a computer systemmay be an example environment 100 and reference number 100 isinterchangeably used to reflect this. A computer system 100 may beimproved by inclusion of at least software adapted to perform featuresas detailed herein. All of or a portion of such a computer system 100may be used to implement a web-based application adapted to open asession in a web-based application so that the session may be associatedwith the immutable virtual pre-site study using a first computing devicethat is linked to the session and that is associated with the frame andglasses subsystem. A computer system 100, as shown in FIG. 1 , may alsobe used as a second computing device that may allow a first computingdevice and other computing devices to join such a session opened via itsweb-based application.

A system for a virtual immutable pre-site study includes at least oneprocessor and memory, such as storage modules. In at least oneembodiment, one or more chassis 102 (and its internal components) may beused to implement part or all of one or more embodiments of a system andmethod for immutable virtual pre-site study that is detailed herein. Oneor more elements of computer system 100 (such as, a monitor 106, akeyboard 104, and/or a mouse 110) may also be used to implement part ofall of one or more embodiments of the system and methods describedherein.

Computer system 100 may include chassis 102 that includes one or morecircuit boards, a Universal Serial Bus (USB) port 112, a Compact DiscRead-Only Memory (CD-ROM) and/or Digital Video Disc (DVD) drive 116, anda hard drive 114. One or more circuit boards may include at least oneprocessor to execute instructions stored on associated memory to performfunction disclosed throughout herein. Elements included, either partlyor fully, on one or more circuit boards inside chassis 102 are furtherillustrated in FIG. 2 .

As shown in FIG. 2 , at least one processor may be a central processingunit (CPU) 210, which may be coupled to a system bus 214. Anarchitecture of CPU 210 may be compliant with any of a variety ofcommercially distributed architecture families but may be adapted toprovide a system for immutable virtual pre-site study by executing codeor instructions from memory associated with CPU 210. The system bus 214may be coupled to memory of a second computing device 100. In at leastone embodiment, such memory is a memory storage unit 208 and may include(i) volatile memory, such as, for example, random access memory (RAM)and/or (ii) non-volatile memory, such as, for example, read only memory(ROM). A non-volatile memory can be removable and/or non-removablenon-volatile memory. RAM-type memory may include dynamic RAM (DRAM) andstatic RAM (SRAM). ROM-type memory may include mask-programmed ROM,programmable ROM (PROM), one-time programmable ROM (OTP), erasableprogrammable read-only memory (EPROM), electrically erasableprogrammable ROM (EEPROM) (such as, electrically alterable ROM (EAROM)and/or flash memory).

The memory storage module(s) may include memory storage unit 208 and anexternal memory storage drive. An external memory storage device may bea USB-equipped electronic memory storage drive coupled to a universalserial bus (USB) port 112 (as illustrated in FIGS. 1-2 ), hard drive 114(also as illustrated in FIGS. 1-2 ), CD-ROM and/or DVD drive 116 (alsoas illustrated in FIGS. 1-2 ), a floppy disk drive, an optical disc, amagneto-optical disc, and magnetic tape. Furthermore, non-volatile ornon-transitory memory storage module(s) refer to the portions of thememory storage module(s) that are non-volatile (and may includenon-transitory type) memory.

Portions of the memory storage module(s) of the various embodimentsdisclosed herein (such as portions of the non-volatile memory storagemodule(s)) may be embedded with a boot code sequence suitable forrestoring computer system 100 to a functional state after a systemreset. In addition, portions of the memory storage module(s) of thevarious embodiments disclosed herein (such as portions of thenon-volatile memory storage module(s)) can comprise microcode such as aBasic Input-Output System (BIOS) operable with computer system 100.Portions of a memory storage module(s) may include an operating system,which can be a software program that manages hardware and softwareresources of a computer system 100 and/or a computer network.

A BIOS can initialize and test components of computer system 100 and canload such an operating system. An operating system can perform basictasks such as, controlling and allocating memory, prioritizing theprocessing of instructions, controlling input and output devices,facilitating networking, and managing files. Additional instructions maybe included to support features for an immutable virtual pre-site study,include to enable secure connectivity to a cloud environment and toenable secure communications with other devices associated with asession opened using the computer system 100.

Other operating systems may be used with a computer system 100 and anapplication for an immutable virtual pre-site study may be implementedon such other operating systems, including on one of the following typesof operating system: (i) Microsoft® Windows® operating system (OS) byMicrosoft Corp. of Redmond, Wash., United States of America, (ii) Mac®OS X by Apple Inc. of Cupertino, Calif., United States of America, (iii)UNIX® OS, and (iv) Linux® OS. Further exemplary operating systems cancomprise one of the following: (i) the iOS® operating system by AppleInc. of Cupertino, Calif., United States of America, (ii) theBlackberry® operating system by Research In Motion (RIM) of Waterloo,Ontario, Canada, (iii) the WebOS operating system by LG Electronics ofSeoul, South Korea, (iv) the Android™ operating system developed byGoogle, of Mountain View, Calif., United States of America, (v) theWindows Mobile™ operating system by Microsoft Corp. of Redmond,Washington, United States of America, or (vi) the Symbian™ operatingsystem by Accenture PLC of Dublin, Ireland.

The least one processor and/or a processing module may be any type ofcomputational circuit, such as but not limited to a microprocessor, amicrocontroller, a controller, a complex instruction set computing(CISC) microprocessor, a reduced instruction set computing (RISC)microprocessor, a very long instruction word (VLIW) microprocessor, agraphics processor, a digital signal processor, or any other type ofprocessor or processing circuit capable of performing the desiredfunctions. Further, one or more processing modules disclosed herein mayinclude a CPU 210.

FIG. 2 also illustrates various I/O devices such as a disk controller204, a graphics adapter 224, a video controller 202, a keyboard adapter226, a mouse adapter 206, a network adapter 220, and other I/O devices222 can be coupled to system bus 214. A keyboard adapter 226 and mouseadapter 206 are coupled to keyboard 104 and mouse 110, respectively, ofcomputer system 100. While a graphics adapter 224 and video controller202 are indicated as distinct units in FIG. 2 , video controller 202 canbe integrated into graphics adapter 224, or vice versa. A videocontroller 202 may be suitable for monitor 106 to display reports andimages on a screen 108 of a computer system 100. Further, a diskcontroller 204 can control a hard drive 114, a USB port 112, and aCD-ROM drive 116. However, distinct units may be used to control each ofthese devices separately.

FIG. 2 also illustrates a network adapter 220 that may be used toconnect a computer system 100 to a computer network by wiredcommunication (such as, a wired network adapter) and/or wirelesscommunication (such as, a wireless network adapter). A network adapter220 may be plugged or coupled to an expansion port in computer system100. Alternatively, a network adapter 220 may be built into computersystem 100. In at least one embodiment, a network adapter 220 may bebuilt into a computer system 100 by being integrated into one or morecircuit boards, such as a motherboard chipset. Still further, a networkadapter may be implemented via one or more dedicated communicationchips, connected through a PCI (peripheral component interconnector), orconnected via a PCI express bus of computer system 100 or through a USBport 112. Many other components of computer system 100 and theirinterconnection may be understood to those of ordinary skill in the artupon reading the present detailed description.

When a computer system 100 is running, program instructions (such as,computer instructions) stored on one or more of the memory storagemodule(s) of the various embodiments disclosed herein can be executed byat least one processor, such as by CPU 210. At least a portion of theprogram instructions (or plainly, instructions), may be stored on suchdevices, and may be used for implementing a system and method for animmutable virtual pre-site study.

A computer system 100 may have a different form factor while stillhaving functional elements similar to those described throughout thisdetailed description. In at least one embodiment, a computer system 100may include a single computer, a single server, or a cluster orcollection of computers or servers, or a cloud of computers or servers.Such further system detail is illustrated in at least FIGS. 3 and 14 . Acluster or collection of servers may be used when demand on a computersystem 100 exceeds a reasonable capability of a single server orcomputer. A computer system 100 may also include a portable computer,such as a laptop computer, in a different form factor than illustrated.A computer system 100 may also include a mobile electronic device, suchas a smartphone or a tablet. A computer system 100 may comprise anembedded system as well. Furthermore, a first computing device used at aphysical site may include one or more such computer systems but may bemobile versions to support movement of a study coordinator at a researchsite.

FIG. 3 illustrates aspects of a system 300 for an immutable virtualpre-site study according to at least one embodiment herein. Further,system 300 may be adapted for an immutable virtual pre-site study tosupport clinical trials. System 300 may include a computer system 100and other components adapted to enable hardware and/or software tofunction cooperatively. System 300 may therefore include at least oneprocessor and memory having instructions that when executed by the atleast one processor cause the system 300 to perform functions thatenable an immutable virtual pre-site study.

In at least one embodiment, a CRA and/or clinical research trialparticipant can use a laptop or desktop with a monitor, such as thecomputer systems described in FIG. 1 and FIG. 2 . Further, a CRA may usefield devices at a CRA's location 308. A CRA's location may be remotefrom a research site but may also be remote from other componentsrequired to enable a system 300 for immutable virtual pre-site study. ACRA's field device may include a computer system (such as a computersystem 100) with limited local storage 308. The CRA's location and thefield devices of the CRA's location are interchangeably referenced bythe same numeral reference 308.

A CRA's field device may be a second computing device as describedthroughout herein. Such a second computing device communicates with atleast one field device at the research site 309. As such, at least onefield device at a research site and the research site itself areinterchangeably referenced by the same reference numeral 309. The fielddevices at the research site 309 include one or more first computingdevices, and may be used by a study coordinator when conducting the siteinspection. The second computing device 308 may be used to open asession in a web-based application, such as a virtual site monitoringapplication 301 that may have a front-end provided by a website host316. Such as session may be associated with an immutable virtualpre-site study using a first computing device (physically at a researchsite 309) that is linked to the session and that is associated with theframe and glasses subsystem.

A first computing device may be joined to the session after permissionis granted by a second computing device. The session may be hosted on acloud server that has its own storage 315. A network, such as theinternet 314, may be used to enable the first computing device and thesecond computing device to communicate. A website host 316 may be usedto provide aspects of a web-based application. As such, a web-basedapplication 301 may be a collective feature of one or more computingdevices that are collectively referred to as a second computing devicethat interface with a web-based application. The first computing devicemay be physically remote from the one or more computing devicesinteracting over the web-based application 301. Moreover, a session maybe collectively a secure communication channel, a secure website, asecure webpage, and a secure storage system.

In at least one embodiment, a web-based application system 301 may be avirtual site monitoring application or a virtual site monitoringapplication for system 300. The virtual site application system 301 mayinclude an administrative module 302, configured to permit a CRA andparticipants of the clinical research trial or site inspection to storeinformation regarding scheduling and appointments, such as on-demandappointments, for the PSSV. The system or application may support avideo session 303 capable of retrieving an audio and video stream from aframe and glasses subsystem 310. The frame and glasses subsystem 310includes capability for a high definition (HD) video stream using acamera device, which may be integrated with or contained within theframe and glasses, or may be connected thereto. The camera devicecoordinates with a first computing device at a research site 309 tostart capturing a video stream. The first computing device located atthe research site 309 may be a smartphone 313 that executes instructionsfor part of an immutable virtual pre-site study. In at least oneembodiment, such instructions may be package as an application for thesmartphone 313.

A GPS device 311 may be integrated into or associated with a frame andglasses subsystem that may be represented by a combination of referencenumerals 310, 311. The PSSV application system 301, which includes anadministrative module 302, video session capturing application 303,video chat module 304, live video streaming functionality 305,screenshot capturing and display module 306, and file transfer andcommunication module 307, may be provided at a research site 309 toenable a study coordinator to capture and stream video to a CRA computersystem 308. The GPS 311 enables location tracking, upon instruction fromelsewhere in system 300. In at least one embodiment, such locationtracking may be for one or more locations of the frame and glassessubsystem during the immutable virtual pre-site study.

In conducting a site inspection, a study coordinator may use fielddevices on a research site 309 to stream video (or video data) to aweb-based application, such as a virtual site monitoring application. Inat least one embodiment, system 300, using a frame and glasses subsystem310, with its HD streaming camera and integrated GPS device 311, mayfirst communicate using near-field proximity communications, with afirst computing device, which may be the smartphone having a virtualsite monitoring mobile application (or virtual an immutable virtual PSSVmobile application) 313. Alternatively, the GPS device 311 can beincluded in the mobile device in communication with the frame andglasses subsystem. For example, when a smartphone executing the mobileapplication is in wired or wireless communication with the frame andglasses subsystem, a GPS device embedded with the smartphone may be usedto provide GPS information that is associated with audio and videostreams captured by the frame and glasses subsystem.

Moreover, audio may be captured by the smartphone and associated withthe video streams captured by the fame and glasses subsystem. The studycoordinator may wear the frame and glasses subsystem, which may be inwired or wireless communication with the mobile or computing device,such as a smartphone, executing a mobile application 313. In at leastone embodiment, such a virtual site monitoring mobile application 313 isdistinct from a web-based application or may be a component of such asweb-based application. In at least one embodiment, a virtual sitemonitoring immutable associations from information in such data. In atleast one embodiment, a virtual site monitoring application, differentfrom the virtual site monitoring mobile application, may be executing ata second computing device 308.

A second computing device 308 may enable transmission of a script from aweb-based application to a first computing device, such as to smartphonewith its application 313. The first computing device 313 may be remotefrom a second computing device 308 (and may include 316) interfacingwith the web-based application. The script may be generated using thesecond computing device 308 interfacing with a web-host 316 and a cloudstorage having a database 319. For example, a script may be generatedusing a form creation application of a web-based application, asillustrated at least in FIGS. 13A-13C. Generated scripts may then beassociated with a video stream from a camera of the frame and glassessubsystem and with the location tracked from a GPS 311. Where audio datais also to be captured, this audio data may additionally be associatedwith the script.

The camera or a first computing device may be enabled for filteringcertain content in real-time. For example, the camera or a firstcomputing device may be enabled for filtering the video stream forprivacy protection of patient information if any patient information isexposed at a research site. Such filtering may be enabled by blurring ofmatter that is irrelevant to an immutable virtual PSSV. Matter thatshould be filtered may be determined beforehand and information and datain relation to a site inspection conducted may be subject to such afilter before being communicated to a first computing device. In atleast one embodiment, faces may be blurred from either in-personsubjects or photos posted anywhere in a field of view. Further, papers(or other printed material) may not be captured till express permissionis provided by a study coordinator at a research site using a mobileapplication. Still further, when a study coordinator enters an areahaving a patient or patient information, the first computing device isable to execute instructions to blur a background associated with thepatient. In addition, it is possible to automatically shut of anycameras and microphones till the study coordinator has cleared the areaof patient information or till the study coordinator confirms that nopatient information is visible.

Scripts for conducting the site inspections may be provided with anidentifier so that it may be displayed on the smartphone (the firstcomputing device 313) or other computing device of a study coordinatorat an inspection site when it is determined, such as through GPSinformation, that the study coordinator is at the appropriate location.In an example, a script may include computer code or instructions, andquestions for a study coordinator. The determination of an appropriatelocation may be made on the first computing device, or may be made by asecond computing device 308 operated by a CRA at a remote location afterreceiving the GPS information. For example, when a study coordinator isat a specific location determined by a GPS as coinciding with aninspection action, a script may provide questions seeking responsesassociated with such an inspection action. The script may be formed outof a form creation application and may have sections for inspectionactions, locations, and questions. Responses to the questions, audiodata, video data, photographs, and other information captured inaccordance with or in response to the script may be immutably associatedwith a time stamp, with a location, and with a device identifier. Thetime stamp may be from a video stream and/or an audio stream that may besynchronized at a later time or concurrently with being stored andtransmitted to a cloud server 315.

As noted above, a study coordinator may wear the frames with glassessubsystem (such as, wear glasses 310; 600 in FIG. 6 ; having the HDstreaming capability with a camera device embedded within or attached tothe glasses or the frame of the subsystem). The study coordinator maythen use a first computing device (such as a smartphone having thevirtual site monitoring mobile application 313) to communicate to andfrom the frame and glasses subsystem. The study coordinator may connecta smartphone 313 to a camera either integrated with or connected to theglasses and frame subsystem 310 by a near-field proximity communication,such as Bluetooth®, or even broader range but local communication suchas Wi-Fi®. Alternatively, a wired connection may be provided between theglasses and frame subsystem, including the camera, and the smartphone.

The smartphone or other computing device 313 may adapted to store one ormore video streams or data from the camera 310, and can further streamany video streams or data to field devices 308 at a CRA's location. Thesmartphone or other computing device 313 may be used to stream a videostream or data to field devices 308 at a CRA's location using a system700 described in FIG. 7 . During an inspection, a transmitted scriptfrom a field device 308 may be displayed with the video stream on afirst computing device used by the study coordinator at the inspectionsite, which may be smartphone 313. Furthermore, the script enablesresponses from the first computing device 313. The smartphone 313, orother computing device, via its virtual site monitoring mobileapplication, enables immutable association of two or more of locations,time stamps, the video stream, the responses to the script, or a deviceidentifier. Such immutable associations may be by marking a file withmetadata, tags, or encryption that prevents changes to such information.

Data retrieved from the frame and glasses subsystem 310 may be stored inthe smartphone or other computing device 313, along with data capturedby the smartphone or other computing device itself. The smartphone orother computing device 313 may transmit this data to a cloud server 315via an internet 314 connection. A virtual site monitoring application301 used (such as accessed) on a field device 308 at a CRA's locationmay include live video streaming 305. Data transmitted from thesmartphone or other computing device 313 to the internet 314 (to thecloud server 315) may be also transmitted or accessed from the virtualsite monitoring application 301, on the field devices 308 at the CRA'slocation. Reference numeral 308 is interchangeably used to indicatefield device or location and it is understood and made explicit as towhich aspect is being discussed in embodiments herein.

The video stream or data may stream in real-time 305 to CRAs and/orother participants as a study coordinator conducts an immutable virtualPSSV using glasses 310; 600 embedded with the camera 310. The virtualsite monitoring application 301, which may be executed by the smartphoneor other computing device 313 used by the study coordinator, may includea video chat module 304 for video chat sessions between a first and asecond computing devices. The video chat session or video session may bean open transmission between the two computing devices. In at least oneembodiment, based in part on a video session enabled between the firstcomputing device and the web-based application on the second computingdevice, an override may be enabled for the script. An override may beenabled by an instruction associated with the video session. In at leastone embodiment, an override may be implemented by changes to a formassociated with the script. In at least one embodiment, an override maybe implemented by persisting a script to continue presenting outside aGPS location identified for the script (or portion thereof).

A CRA or study monitor can transmit text messages (as part of a textchat session) to a study coordinator using the chat module, which mayhave a text field configured to send data from the field device 308 atthe CRA and/or other participants' locations to the smartphone or othercomputing device 313 via an internet network 314. Such a text chatsession or text session may be an open transmission between the twocomputing devices. Based in part on a video session enabled between thefirst computing device and the web-based application on the secondcomputing device, an override may be enabled for the script. An overridemay be enabled by an instruction associated with the text session, andmay be implemented by changes to a form associated with the script. Forexample, an override may be implemented by persisting a script tocontinue presenting outside a GPS location identified for the script (orportion thereof). In at least one embodiment, a text session or a videosession may be part of a session opened by a web-based application.

A CRA can take a screenshot of video stream or data transmitted fromsmartphone or other computing device 313 to a field device 308 at aCRA's location. Data transmitted from a smartphone or other computingdevice 313, via an internet network 314, may be transmitted to a websitehost 316 that may be configured to store said data via a cloud server315 and its associated database 319. A cloud server 315 may beassociated with or may include storage modules 317-319 dedicated todifferent types of data (video stream, still shots, and clinical trialdata).

The virtual site monitoring application 301 may include a file transferand e-mail module 307, which may be used by a CRA, study coordinator,and/or other participants. The file transfer and email module may allowfor any type of electronic communications to be sent and received, suchas data files, text files, email, and text messages. The module 307 maybe used to upload documents to the virtual site monitoring application301. For example, data transmitted from a smartphone or other computingdevice 313 to an internet network 314 (for benefit of a cloud server 315or a virtual site monitoring application 301) may be transmitted to thecloud server 315 which configured to store said data. Cloud storage canstore different aspects of an immutable virtual pre-site study video,including streaming files from the video session 317, camera still shots318, and a clinical trial database with session folders 319.

The clinical trial database with session folders 319 may include astructured (such as, indexed) collection of data and may be adapted tobe managed by any suitable database management systems. The databasemanagement systems may be able to define, create, query, organize,update, and manage database(s). And, the database management systems mayinclude one or more of: a MySQL® (Structured Query Language) Database, aPostgreSQL® Database, a Microsoft SQL® Server Database, an Oracle®Database, an SAP® (Systems, Applications, & Products) Database, or anIBM DB2® Database.

Communication between the smartphone or other computing device 313, theglasses 310, the field devices at the CRA's location 308, and/or the oneor more databases may be implemented by wired and/or wirelesscommunication therebetween. Therefore, system 300 may include softwareand/or hardware components configured to implement such wired and/orwireless communication. Further, the wired and/or wireless communicationmay be implemented using any one or a combination of wired and/orwireless communication network topologies (such as, ring, line, tree,bus, mesh, star, daisy chain, hybrid, etc.). The wired and/or wirelesscommunication may be also implemented using any one or a combination ofwired and/or wireless communication protocols (such as, personal areanetwork (PAN) protocol(s), local area network (LAN) protocol(s), widearea network (WAN) protocol(s), cellular network protocol(s), powerlinenetwork protocol(s), etc.). Exemplary PAN protocol(s) can compriseBluetooth, Zigbee, Wireless Universal Serial Bus (USB), Z-Wave, etc.;exemplary LAN and/or WAN protocol(s) can comprise Institute ofElectrical and Electronic Engineers (IEEE) 802.3 (also known asEthernet), IEEE 802.11 (also known as Wi-Fi), etc.; and exemplarywireless cellular network protocol(s) can comprise Global System forMobile Communications (GSM), General Packet Radio Service (GPRS), CodeDivision Multiple Access (CDMA), Evolution-Data Optimized (EV-DO),Enhanced Data Rates for GSM Evolution (EDGE), Universal MobileTelecommunications System (UMTS), Digital Enhanced CordlessTelecommunications (DECT), Digital AMPS (IS-136/Time Division MultipleAccess (TDMA)), Integrated Digital Enhanced Network (iDEN), EvolvedHigh-Speed Packet Access (HSPA+), Long-Term Evolution (LTE), WiMAX, etc.

The communication software and/or hardware used may depend on networktopologies and/or protocols implemented, and vice versa. Exemplarycommunication hardware may include wired communication hardwareincluding, for example, one or more data buses, such as universal serialbus(es); and one or more networking cables, such as, coaxial cable(s),optical fiber cable(s), and/or twisted pair cable(s). Further exemplarycommunication hardware may include wireless communication hardware, suchas one or more radio transceivers and one or more infrared transceivers.Additional exemplary communication hardware may include one or morenetworking components (such as, modulator-demodulator components,gateway components, etc.).

System 300 may also include one or more input devices (such as, one ormore keyboards, one or more keypads, one or more pointing devices suchas a computer mouse or computer mice, one or more touchscreen displays,microphone, etc.), and/or can comprise one or more display devices (suchas, one or more monitors, one or more touch screen displays, projectors,etc.). In at least one embodiment, one or more of the input device(s)can be similar or identical to keyboard 104 and/or a mouse 110 shown inFIG. 1 . Further, one or more of a provided display device(s) may be amonitor 106 and/or screen 108.

The input device(s) and a display device(s) may be coupled to aprocessing module(s) and/or the memory storage module(s) of system 300in a wired manner and/or a wireless manner, and the coupling can bedirect and/or indirect, as well as locally and/or remotely situatedcomponents. An indirect input/output component may include akeyboard-video-mouse (KVM) switch that may be coupled to provide inputdevice(s) and to provided display device(s). The coupling may alsoinclude a coupling to a processing module(s) and/or a memory storagemodule(s). The KVM switch also can be part of system 300. In addition,processing module(s) and a memory storage module(s) may be local and/orremote to each other.

FIG. 4 illustrates aspects of a method 400 for an immutable virtualpre-site study according to at least one embodiment herein. While thisdescription is provided with respect a pre-site study, the method mayalso be used to implement other site studies and inspections, including,follow-up inspections, compliance inspections, trial visits andinspections, and trial-end visits and inspections. The method 400 may beimplemented on a system 300 or other systems, such as systems previouslydescribed and further described in subsequent figures herein, and anorder of activities in a method 400 herein may be changed but stillresults in an immutable virtual pre-site study of the present detaileddescription. For any particular inspection and study, the steps ofmethod 400 may be performed in any suitable order. In addition, certainof the steps or sub-steps that may be combined or skipped. One or moresteps or sub-steps of method 400 may be implemented via computerinstructions configured to executed on one or more processing modulesthat may be at least one processor, such as the processing module(s)described above with respect to computer system 100.

The method 400 may include a step or sub-step (also referred to as anactivity) 401 of contracting and storing administrative paperworkincluding for Health Insurance Portability and Accountability Act(HIPAA) compliance in a virtual site monitoring application system 301that is associated with at least one field device, such as a secondcomputing device 308 of a CRA's location. The method 400 may include anactivity 402 for opening a new session and to setup a session in avirtual site monitoring application 301 and on the smartphone or othercomputing device 313. The session may also establish the virtual sitemonitoring application system with cloud storage 317-319 and web host316.

The method may further include an activity 403 of loading sessioninformation data, including necessary equipment information for aclinical research trial. In at least one embodiment, volunteersavailable for a clinical research trial may be part of such information.Information pertaining to facilities of a clinical research trial may bestored in memory located within the cloud server 315 and/or websiteserver 316. Activity 403 may include a feature for associating a scriptwith an audio stream. This audio stream may be synchronized with a videostream and may be provided to a user (such as a study coordinator) ofthe first computing device or a user (such as the CRA or otherparticipants) of the second computing device.

Method 400 may include an activity 404, by a CRA, of scheduling avirtual site monitoring session or sessions using a virtual sitemonitoring application 301. In at least one embodiment, at such ascheduled time, a session may be opened, and participants may request orbe allowed to join. In addition, the method may include an activity 405of starting a pre-trial session, such as by clicking on a button on thevirtual PSSV application. In addition, activity 405 may include enablingor allowing a study coordinator to join and participate in a virtualsite monitoring session started by a CRA. Alternatively, a studycoordinator may start an unscheduled visit. When an unscheduled visit isstarted, the study coordinator may contact a CRA or other participant,and request that the CRA or other participate create a virtual sitemonitoring session or sessions for the unscheduled visit. Starting thesession, as shown in activity 405, may include the steps described belowwith respect to FIG. 5 .

During the session, the method may collect information and storerelevant information for the session via an activity 406. Thiscollection and storage of information may include transmission, viasystem 300, of locations, time stamps, video stream, responses to ascript, and device identifier, to a web-based application from a firstcomputing device. Activity 406 may include immutable storage enabled ofsuch information Immutable storage may be enabled by storing suchinformation as read-only data in the cloud storage Immutable storage maybe also enabled by encryption, metadata, or distributed ledgers. Forexample, a distributed ledger enables each piece of data stored to berecorded in a distributed ledger which is updated if any changes aremade to the data. Such changes may be rejected when a report isgenerated, thereby making the data immutable. Relevant parts of suchinformation collected during a session may be stored in a cloud server315 or a website host 316. The method 400 may also include an activity407 of conducting additional sessions following the steps described in401-405. When no more trial sessions are required or desired, the methodmay end.

FIG. 5 illustrates other aspects of a method 500 for an immutablevirtual pre-site study according to at least one embodiment herein. Themethod 500 may be implemented on a system 300 or other systems, such assystems previously described and further described in subsequent figuresherein. The order of activities in method 500 herein may be changed, butstill results in an immutable virtual pre-site study of the presentdetailed description. The method 500 may be performed in any suitableorder, and may include steps or sub-steps that may be combined orskipped. One or more steps or sub-steps of a method 500 may beimplemented via computer instructions configured to executed on one ormore processing modules that may be at least one processor, such asprocessing module(s) similar or identical to the processing module(s)described above with respect to computer system 100.

The method 500 may include an activity 501 of opening a pre-site studyvisit session in a virtual site monitoring application 301 using one ormore field devices 308 at a CRA's Location. The method may also includean activity 502 of joining a session opened via a virtual sitemonitoring application. This session may be opened in a cloud computingenvironment via web host 316 and using cloud server 315. Joining such asession may include associating a first computing device and a secondcomputing device with the session in the cloud computing environment.Joining such a session may also include an activity of controlling entryof third-parties to participate in the session. In at least oneembodiment, this may be by receiving requests from such third-parties(such as, from other participants) and approving or denying suchrequests.

Field devices (such as a second computing device) 308 at a CRA'slocation may be used to join third-parties to the session. Multipleparticipants can join a session, including the study coordinator, moreCRAs, doctors, and other participants (including clinical research trialparticipants). The method may include an activity 503 of walking througha research site with live video streaming from an HD camera embeddedglasses 310. For example, a site or study coordinator may wear theglasses 100, and walk through the site such that live video and audioare captured by the camera, transmitted to a mobile or computing device,such as a smartphone, used by the coordinator, and then streamed to afield device at the CRA's location. The HD camera may be associated witha frame and glasses subsystem and may be within a lens of the subsystem.Alternatively, the camera may be formed integrally with, embedded in, orattached a frame of the subsystem. As mention, a study coordinator maywalk through a research site with live video streaming from such a HDcamera.

The method 500 may include an activity 504 of conducting a session byasking questions on the video chat module 304. These questions may comefrom a CRA or other participates, using the text chat module. In atleast one embodiment, such a feature represents an ability of system 500to incorporate overriding a script by an instruction associated with thevideo session. In some embodiments, a CRA and/or other participants mayalso provide questions to override a script. This may be similarlyimplemented for text chat instead of a video session. In at least oneembodiment, a text chat module 307 may be used to implement such featureinstead of or together with a video chat module 304.

A virtual site monitoring application (web-based application) may beused to populate pre-made questions to a CRA and/or other participantsin a script using a form and a form creation application, such as inFIGS. 13A-C. The CRA or other participates may then use this script toask questions or direct the study coordinate during the session. Thequestions from a script may automatically synchronize with a videostream based in part on GPS location of a frame and glasses subsystem,and the script may be presented with the video stream based in part onthe locations being associated with inspection actions during animmutable virtual pre-site study. For example, certain equipment may beat a specific location for a specific use.

In addition, inspection of such equipment may be tied to an inspectionaction—such as space and processing capability of a machine. Forexample, questions may be provided from a script depending on such alocation within a research site. Based on image identification of anequipment, questions may be presented from a script. Moreover, aweb-based application enables association of the script with the videostream, the timestamps, and the location in an immutable manner, priorto transmission from the first computing device to the web-basedapplication. The questions provided via video or text may be used tooverride the script and may be provided directly to the studycoordinator. CRAs and/or other participants may also create customquestions in a virtual site monitoring application 301 to ask a studycoordinator during the session via a script.

The method may also include an activity 505 of reviewing a checklist.This may include enabling a CRA to go through a checklist and to recordanswers and images provided by a site coordinator using a frame andglasses subsystem associated with a first computing device. A studycoordinator may participate in a live question and answer session usinga video session module 303 in a virtual site monitoring application 301,and the participation may result in answers and images recorded andassociated with a script. The method may also include an activity 506 ofcompleting the session. Activity 506 may include generating a reporthaving the locations, the time stamps, the video stream, the responsesto the script, and the device identifier. This report may be providedfrom the first computing device or from the web-based application on thesecond computing device to any requesting device or to be stored in thecloud storage 315.

Other information entered into a virtual site monitoring application canbe archived into the cloud server 315 and/or website server 316. Thisinformation may include, by example, identification, sex, birthdate,age, race, ethnicity, language, visit status, date and time, visit type,class, and method (video or audio) of a session. In at least oneembodiment, a smartphone or other computing device 313 may store date,time, and length of time of a session, and may further be associatedwith GPS features as described with respect to FIG. 3 , such that theGPS can provide location information which is also stored.

For example, the smartphone or other computing device 313 may be used tostore a location of a research site during a session using a GPS totrack such a location. The smartphone or other computing device 313 maytransmit data including, by example, location the date, time, length oftime, and a location of a research session to a virtual site monitoringapplication. In at least one embodiment, at an end of a session, suchinformation may be archived into a visit summary that forms a report asalso described with respect to at least activity 506. The archived visitsummary may be stored in a cloud server and/or a website server.

FIG. 6 illustrates a frame and glasses subsystem 600 for an immutablevirtual pre-site study according to at least one embodiment herein. Theframe and glasses subsystem 600 includes a frame 601 with respectiveglasses (or referred to as lenses) 602 and 603. The subsystem 600 mayinclude goggles, glasses (including frames), or any form of opticalwearables. The lenses of the glasses fit within channels in the frame601. The frame 601 has legs 604, which may be pivotally attached tohinges 605. In at least one embodiment, connectivity is provided betweenlegs 604 and glasses 602, 603.

The frame 601 may have a bridge with nose pads 606 formed within orattached to a frame 601. A camera 607 (a video or still camera) may beembedded within provided lens 602 and/or 603. Alternatively, the cameramay be mounted on the frame 601 of the glasses, formed integrally withthe frame 601, or otherwise connected to the frame 601. The camera 607may be high definition (HD) camera, which can capture HD video and HDstill photographs. The camera comprises may include an image processor609, a storage device 610, an image buffer 611, and a compression module612. In addition, the camera may be configured to detect, process,transfer, store, and/or replay video image data between the frame andglasses subsystem and a first computing device (as illustrated in FIG. 7).

FIG. 7 illustrates a communication aspects in a system 700 for animmutable virtual pre-site study according to at least one embodimentherein. In particular, FIG. 7 illustrates a system and method in which amobile phone (such as a smartphone forming the first computing device705) streams a video stream or data to a CRA/participant(s)' computer.In at least one embodiment, such a smartphone 705 (or 313 in FIG. 3 ) isable to connect to a camera 310 (607 in FIG. 6 ) embedded within theglasses 704. The smartphone (such as smartphone 313 of FIG. 3 ) includesa virtual site monitoring mobile application configured to activate acamera embedded within or associated with the glasses 704.

The smartphone or other computing device 313 may have a GPS device 311(which may be an integrated GPS device) to track location of a frame andglasses subsystem or a smartphone, which then facilities wirelesscommunication to computing devices outside a research site. An imageprocessor 609 within the camera may be able to retrieve image data, andthe camera may be able to transmit video stream or data to a smartphone705. Then, the smartphone 705 may be able to transmit packets of a videostream or of video data to cell phone towers 701 via radio waves. Forexample, video stream or data may be transmitted from a cell phone tower701 to a router 702. The router 702 directs each packet to an internettype of network 703, and the network 703 may be able to transmit data toa virtual site monitoring application 301 stored on or accessible to afield device 308 at a CRA and/or other participants' locations.

FIGS. 8-12 illustrate user interface aspects 800-1200 for an immutablevirtual pre-site study according to at least one embodiment herein. Inat least one embodiment, an application 806 includes scheduled andon-demand appointments listed, along with an option 808 to start or opena session. The application 806 may be accessible as a web-basedapplication within a browser 802 via a website link 804. Alternatively,the application 806 may be accessible via a standalone web application,or may be provided as an application running on a mobile device. Thesessions started or opened, including based on scheduled or on-demandappointments, may be associated with the immutable virtual pre-sitestudy where a study coordinator is located at a research site. Duringthe session, a first computing device at a research site is linked tothe session, and an immutable virtual pre-site study may be performedusing the first computing device that is linked to the session and thatis associated with a frame and glasses subsystem.

FIG. 9 illustrates user interface aspects 900 after a session option 808is selected. A research site's study coordinator may be represented by afirst listing in a session section 902, and CRAs 904 may be subsequentlylisted. Selecting a listing in session section 902 allows denial ofpermission to a third-party participant in a session. As shown in FIG. 9, the interface may present a chat interface for a study coordinator andCRA or other participant to communicate and join a session.

FIG. 10 illustrates a user interface (UI) 1000 of the virtual siteapplication having a video stream 1004 that has a coordinated orsynchronized portion 1002 of a script within an application. The userinterface 1000 also includes a section video of a CRA monitoring actionsof a study coordinator. The script may be transmitted from a web-basedapplication of a CRA (on a second computing device) to a first computingdevice located at a research site, with the second computing devicebeing remote from the first computing device. The script (or portion1002 thereof) may be associated with a video stream 1004 from a cameraof a frame and glasses subsystem and with a location determined by a GPSfor the frame and glasses subsystem. The UI 1000 also illustratesresponses 1008 enabled by the script 1002.

FIGS. 11 and 12 illustrate user interface (UI) aspects 1100, 1200 of anapplication on a first computing device or a second computing device.Upon completion of an immutable virtual PSSV, the application is able togenerate a report or a visit summary which may include information 1102,1202 gathered during the an immutable virtual PSSV the locations, thetime stamps, the video stream, the responses to the script, and thedevice identifier. The device identifier may include an identifier (suchas an internet protocol address or a media access control address of oneor more of a frame and glasses subsystem or a first computing device).In at least one embodiment, such a report may be provided from the firstcomputing device or from the web-based application on the secondcomputing device.

A study monitor (such as at a CRA location) may be able to manage sitestatus via information provided to a CRA and for entry in the siteprofile 810 during planning of an immutable virtual PSSV. The siteprofile may be made available for editing on the immutable virtual sitemonitoring mobile application, where such information and any changesmay then be passed to the web-based application. Site statuses mayinclude pre-qualified, qualified, not qualified, active, closed, andlocked. In addition, the UI of the web-based application or the mobileapplication may be adapted to perform certain functions. For example,when a study monitor adds a site to a study, a system (such as system300) sets a site status to pre-qualified. As such, all sites begin withthis status when they enter the web-based application (for the CRA).

In the UI of FIGS. 8-12 , a site status dropdown may always displays acurrent status of a site when collapsed. Further, when the dropdown isopen the current status appears at the top of a list of statuses with acheckmark next to it. When a study monitor changes a site status, thesystem presents an alert to confirm the intention. To complete the sitestatus change, a study monitor must type or select a word, icon, orselectable option as confirmation they intend to make the change. Forexample, when the site status is pre-qualified, the additional statusesavailable in the site status dropdown will only include qualified or notqualified. The study monitor would then be limited to selecting fromthese limited options.

When the site status is qualified, the additional statuses available inthe site status dropdown will be pre-qualified, not qualified, active,and locked. Further, when the site status is active, the additionalstatus available in the site status dropdown is closed. When the sitestatus is closed, the only additional status available in the sitestatus dropdown is: locked. Further, when the site status is locked, thesite status dropdown displays this status, but the dropdown may be in adisabled state. The site status then cannot be modified.

When a study monitor attempts to change the site status and when thereare scheduled visits for the visit types associated with that sitestatus, the application may alert the study monitor that they mustcancel or complete all scheduled visits before changing the site status.When the study monitor attempts to change the site status, but there areincomplete or unresolved visits for the visit types associated with thatsite status, the system alerts the study monitor that they must completeor resolve all pending visits before changing the site status.

There may be two user account types for the application 301 executing onat least one computing device of a system 300, such as in a cloud server315, a website host 316. A first account is for a study coordinator anda second account is for a study monitor. As described herein, a studycoordinator may act as the “eyes” for the study monitor to see a siteduring a site visit. The study monitor can manage large studies withmany sites throughout the lifecycle of a study. As such, there may bemultiple sessions maintained distinctly and immutable from each other.

When a new site seeks qualification for a study, the study monitor cancreate a new site profile using UI aspects 800 and can begin aqualification workflow. Study monitors can invite site staff (such as,study coordinators) to create an account in association with thequalification workflow. Study coordinators may then activate theiraccount in preparation for an immutable virtual PSSV. When a studymonitor has multiple sites seeking qualification, the study monitor maymanage the research sites by maintaining a status for each research sitein a study. In addition, the provided UI aspects 800 also support othertypes of visits, such as a training visit, a compliance visit, andtrial-end visit.

Research sites may also enter a study with a status of pre-qualified.Then, using immutable virtual site monitoring visits (presentingimmutable virtual an immutable virtual PSSVs) by the present system andmethod, evaluation may occur for the site throughout the lifecycle ofthe trial. The site status may need changing based in part on how theresearch site functions as part of the study-as covered elsewherethroughout this detailed description. A study monitor can conduct avariety of different types of research site visits (an immutable virtualPSSVs) depending on a research site's status. A research site may besubject to a default visit type, such as a site selection, a siteinitiation, interim monitoring, and closeout.

To begin inspection and evaluation of a research cite, a study monitormay schedule research site visits (an immutable virtual PSSVs) using ascheduler, as illustrated in Application UI 806. A study monitor maythen monitor and maintain an inventory of qualified sites for a studythat can be activated based on needs of such a study. In at least oneembodiment, a study monitor coordinates with research site staff using avariety of communication methods enabled by UI aspects 800, 900. Such UIaspects included chat, video calls, and audio calls.

For a research site visit, a study monitor tours such a research sitevirtually using video streamed (feed or broadcast) from a frame andglasses subsystem having at least eyewear (or glasses) worn by a studycoordinator who may be a research site staff. All research site visitsmay have a defined visit type that is associated with a site's status,as noted elsewhere in this detailed description.

For example, research sites with a status of pre-qualified may have oneor more site selection visits. Separately, research sites with a statusof active, may have one or more interim monitoring visits. Visit typesmay be customizable on a study-by-study basis and may be associated withany site status. A study coordinator may be able to toggle between acamera of a frames and glasses subsystem and that of a first computingdevice (such as a mobile device) at the request of a study monitor via asecond computing device interfacing on a web-based application.

A study monitor may be able to view closeups and take snapshots of whata study coordinator sees. A study monitor may be able to then annotatedirectly on such snapshots or closeups to document a research site'scapabilities. Furthermore, screen sharing may be provided for both, astudy monitor and a study coordinator to facilitate an immutable virtualan immutable virtual PSSV and to conduct training sessions. In terms ofa functional overview of the UI aspects 800-1200, during a research siteinitiation, at least a study coordinator and a study monitor may usetext-based messaging (such as a text chat session) within a waiting roomand/or an encounter room. Such text-based messaging may be tocommunicate as a supplemental option to audio and video communication(via at least a video chat session or a separate audio chat session).These sessions may be part of a session opened via a web-basedapplication of a second computer device at a CRA's location.

In at least one embodiment, a study monitor may open a session via aweb-based application and can invite guests to join research site visitsand request assistance with any research site visit. During a livevisit, a study coordinator can join a video stream using either aweb-based mobile application that may also be a regular applicationassociated with a web-based application of a second computing device. Astudy coordinator may also switch devices (such as using multiple firstcomputing devices at a research site) at any time during a visit torespond to requests from a study monitor. The different devices may beall pre-authorized into a session opened by a web-based application sothat there is a smooth transition between such different first computingdevices.

A study monitor may also have the ability to dismiss participants from asession individually or collectively. For example, a study monitor canend a session, including a call that is a live video/audio communicationwith a first computing device at a research site. While this feature mayclose a session, such closure may be temporary and does not complete animmutable virtual PSSV. Such a feature may, however, dismiss site andguest participants for a determined time period. A study monitor mayremain in an encounter room to complete their notes (such as, inpreparation for a summary or report 1102, 1202 within a web-basedapplication) before marking a visit as successful and completed.Alternately, a study monitor may mark a visit as incomplete and completetheir notes at a different time and in a different location removed froma location of an inspection action or the research site, entirely, as itmay be convenient for the study monitor.

When a technical issue occurs in any of the features of a system (suchas a system 300 in FIG. 3 ), a study monitor can also mark a visit asunresolved so that a visit status for the visit may be addressed at alater time. In at least one embodiment, a visit queue may be enabled asillustrated in the UI aspects 800 of FIG. 8 . During one or moreimmutable virtual PSSVs, a study monitor may review a list of studycoordinators that have started their visits. For example, a studymonitor may be able to determine by a status indicator that such studycoordinators are waiting for a session to be opened to begin such one ormore immutable virtual PSSVs. A study monitor can review details about aresearch site and may be able prepare for each of the one or moreimmutable virtual PSSVs before a walk-through actually begins.

A study monitor may also engage a study coordinator using text-basedmessaging before beginning an immutable virtual PSSV. For example, astudy monitor may be able to flag a site card in a queue with acustomizable scheme to prioritize one or more immutable virtual PSSVswaiting in a queue, such as illustrated in the UI aspects 800 of FIG. 8. A study monitor can also send a notification to other study monitorsabout a specific research site waiting in a queue, if a study is busyand a different study monitor may be able to open a session to conductan immutable virtual PSSV. In the system, a status for sessions areviewable across a web-based application that is accessible on multiplesecond computing devices of multiple CRAs or study monitors.

FIGS. 13A, 13B, 13C illustrate form aspects 1300, 1350, 1380 for ascript to be associated with at least a video stream in a system for animmutable virtual pre-site study according to at least one embodimentherein. As shown in FIG. 13A, a form application 1302 is presented thatmay be part of an application 301 in FIG. 3 , but may alternatively bean independent application. The form application 1302 may result in anunderlying script generated to a format of a UI—as illustrated in FIGS.8-12 . As shown, form application 1302 may include fields 1304 todescribe a nature of an immutable virtual PSSV.

As shown in FIG. 13B, form aspects 1350 illustrates where targetinsertion points 1352 may be defined for indicating where pertinentquestions of a script should be coincided with a video stream. Forexample, when a video stream is at a consultation room, such asdetermined based on GPS coordinates, questions described in the form forsuch a target insertion point may be displayed and may enable responsesfrom a study coordinator. As shown in FIG. 13C, form aspects 1380include selectable options for adding questions or instructions.Questions 1382 may be provided from a library of default or previouslystored questions for the script, or may be generated by a user andprovided in form section 384. A script may be generated by application1300 from the questions. The script may have different sections, eachassociated with a target insertion point. A target insertion point maybe converted to an identifier to be matched with an input or with GPScoordinates as a study coordinator inspects a research site using aframe and glasses subsystem and its associated first computing device.

In addition, configurable forms may be a basis for a script generatedfor a first computing device. For example, an intake form for a studycoordinator may be customized within a web-based application 301 or in aseparate form application 1302. In at least one embodiment, such a formmay be completed upon starting an immutable virtual PSSV or will be turnoff for the intake flow. In at least one embodiment, such a form may becustomized so that a notes form may be displayed in an encounter room ofa research site and so that responses may be provided by a study monitorto complete during an immutable virtual PSSV without a specific question(or using an open question).

A survey may be displayed at an end of an application in a UI aspect toget feedback from a study coordinator and to better understand andassess how an immutable virtual PSSV is performing (or can be improved).All configurable forms may include a variety of standard controls usedin web-based forms, including for a decimal number field, an integerfield, and a dropdown (single-select) option.

In addition, the form application may include a dropdown (multi-select)option, date, radio buttons, text field (multi-line input), text field(single-line input), legal form (requesting to acknowledge and acceptlegal disclaimers, for instance), and a file upload option. In at leastone embodiment, all configurable forms may have one or more sections andcan begin with an instructions view and end with a confirmation view.

All configurable forms may be able to display a set of follow-upquestions based on response to a parent question, such as through ascript having the follow-up questions and the parent questions at atarget insertion point. File sharing may be an optional feature enabledin a UI aspect of the web-based application and the mobile application,to allow allows research sites to securely share files with a studymonitor and vice versa (with a study coordinator). As part of this filesharing, a study coordinators can upload a variety of different filetypes, including PDFs and images, directly before or after an immutablevirtual PSSV.

A study coordinator can access file sharing using either the web-basedmobile application or a variation of the web-based application, whichmay be pre-installed on a first computing device shipped to a researchsite within a research site kit. A visit summary or report 1102, 1202(such as in FIGS. 11 and 12 ) may be provided when an immutable virtualPSSV is completed. In at least one embodiment, all immutable virtualPSSVs produce a visit summary or report to document actions and resultsat such immutable virtual PSSVs. The summary or report is useful for thestudy monitor to use as part of their assessment of a research site, andmay be available from the web-based application as a download in a PDF(or other format) and for printing. To ensure the integrity of thereports is not compromised, these formats may be immutable formats thatdo not allow for changes. The summary or report may include names ofpeople that participated in an immutable virtual PSSV, such as a studycoordinator, a study monitor, and associated guests.

A visit summary or report may include at least a name of a research sitewhere an immutable virtual PSSV was conducted, and can include a dateand time of when an immutable virtual PSSV was conducted, as well as theduration of the immutable virtual PSSV. A visit summary or report mayalso include a type of an immutable virtual PSSV, such as siteselection, and whether such an immutable virtual PSSV was a scheduled oron-demand visit.

A visit summary or report may include a visit status, such as that animmutable virtual PSSV was successful, which may be useful for sitequalification. Alternately, an immutable virtual PSSV with a status ofsite did not attend may indicate one or more additional visits may benecessary. In at least one embodiment, when a visit type of an immutablevirtual PSSV has a configurable form associated with it, a visit summaryor report displays questions and responses received. A study monitor mayadd to the responses and the additional response may be immutably tiedto the summary or report.

When a study monitor captures snapshots during a an immutable virtualPSSV, a summary or report may include those snapshots. When a studymonitor chats with a study coordinator in a waiting room or an encounterroom at a research site, a visit summary or report includes a transcriptof such entire chat.

A visit summary may include any files that were uploaded during animmutable virtual PSSV. For purposes of capacity planning, a schedulerapplication may be used, and a study monitor can set their availabilityfor specific appointment blocks for scheduled visits and to makethemselves available for on-demand visits with research sites requestingfor the same.

Study monitors can also set the availability for a team of studymonitors and can also schedule site visits on their behalf. In addition,staff chats, such as provided via a text (or video/audio) chat sessionmay be a communication tool that allows a study monitor to quicklyconnect with other study monitors managing other parts of a study viachat, voice, or video. In at least one embodiment, study monitors maycontact research site staff at any research site in a study via suchchat sessions without any formality of conducting an immutable virtualPSSV.

In at least one embodiment, the system 300 includes notifications tonotify users of important system events via electronic communications,such as short messaging service (SMS) and electronic mail (email). Allnotifications for a study may be enabled by default. Certain emailnotifications drive key workflows in a study and cannot be turned off.In at least one embodiment, such notifications include: accountactivation email, forgot password email, and the guest invite email thatbrings guests into a session for an immutable virtual PSSV. Other emailand electronic communication notifications may be turned off for aspectsof a system 300 for an immutable virtual PSSV. Such notifications mayinclude new appointment confirmations, appointment updates, cancelledappointment alerts, upcoming visit alerts, and the addition of newfiles. In at least one embodiment, appointment notifications may beconfigured to also alert users via SMS.

A language throughout UI aspects 800-1200, discussed herein may becustomized, including in text messages of various session to suit clientneeds. These language options may also be available to the summary andreports. A lead study monitor may be able to track progress of siteactivity and status across study monitoring teams using filteringcapabilities on a study platform dashboard. In at least one embodiment,reports may be generated to present analytics relevant to a study at theclient's request. Bulk data may be also provided to enable import orexport of large numbers of records into or out of a system 300 at aclient's request while a study is ongoing. A study monitor and a studycoordinator may choose from a list of supported languages for animmutable virtual PSSV to be conducted in a specific language that canthen cause entire UI aspects, including sessions, in both the web-basedapplication and a mobile application to have the same language.

FIG. 14 illustrates a hardware (such as computer and network aspects)aspects 1400 in a system for an immutable virtual pre-site studyaccording to at least one embodiment herein. In at least one embodiment,such hardware aspects 1400 may be mapped to a system 300 of FIG. 3 . Thecomputer and network aspects 1400 may include a distributed system. Inat least one embodiment, a distributed system 1400 may include one ormore computing devices 1412-1416. One or more computing devices1412-1416 may be adapted to execute and function with a clientapplication, such as with browsers or a stand-alone application, and areadapted to execute and function over one or more network(s) 1406.

A server 1404, having components 1406A-X may be communicatively coupledwith computing devices 1412-1416 via network 1406 and via a receiverdevice 1410; 1412, if provided. Components 1406A-X include processors,memory, and random-access memory (RAM). Server 1404 may be adapted tooperate services or applications to manage functions and sessionsassociated with database access 1402 and associated with computingdevices 1412-1416. Server 1404 may also be associated with a firstcomputing device 1414A and directly or indirectly with a frame andglasses subsystem 1414B. For example, server 1404 may be part of a cloudcomputing environment. In at least one embodiment, a second computingdevice 1416 executes a web-based application to communicate with a firstcomputing device 1414A. As such, these computing devices 1416 and 1414Aare at distinct locations from each other.

One or more computing devices may be adapted to transmit, either throughwired or wireless communication channels, information received therein,including dosage information and results from a spectrometer ordetector. This information may be received in a receiver device andtransmitted to a monitor device that infers from changes in electricalproperties based in part on instructions stored therein. The server 1404may include components to function as a web host distinctly from a cloudcomputing environment. In at least one embodiment, one or morecomponents 1406A-X may be adapted to function within a server 1404 forperforming functions discussed with respect to a first computing device308 and with respect to a smartphone or other computing device 313 ofFIG. 3 , and that are associated with a cloud server 315. In at leastone embodiment, one or more components 1406A-X and 1416 may include oneor more processors and one or more memory devices adapted to function asa monitor device, while other processors and memory devices in server1404 may perform other functions.

Server 1404 may also provide services or applications that aresoftware-based in a virtual or a physical environment. When server 1404is a virtual environment, then components 1406A-X are softwarecomponents that may be implemented on a cloud to allow remote operationof certain computing devices, as discussed at least in reference to FIG.3 . This also allows for remote access to information received andcommunicated between any of aforementioned devices. One or morecomponents 1406A-X of a server 1404 may also be implemented in hardwareor firmware, other than a software implementation described throughoutherein. In at least one embodiment, combinations thereof may also beused.

One computing device 1416 may have at least a microcontroller and memoryhaving instructions to enable display of information received from afirst computing device 1414A. Another computing device 1412 may be atransmitter device to transmit directly to a receiver device 1410 or totransmit via a network 1406 to a receiver device 1410 and to a server1404, as well as to other computing devices 1414. The other computingdevices 1414 may include portable handheld devices that are not limitedto smartphones, cellular telephones, tablet computers, personal digitalassistants (PDAs), and wearable devices (head mounted displays, watches,etc.).

The other computing devices 1414 may support applications designed asinternet-related applications, electronic mail (email), short ormultimedia message service (SMS or MMS) applications and may use othercommunication protocols. The other computing devices 1414 may alsoinclude personal computers and/or laptop computers running one or moreoperating systems discussed elsewhere in this detailed description.Thin-client devices, including gaming systems (Microsoft Xbox®) may beused as other computing device 1414. Moreover, network(s) 1406 may beany type of network that can support data communications using variousprotocols. These networks 1406 may be networks that are based onEthernet, Token-Ring, a wide-area network, Internet, a virtual network,a virtual private network (VPN), a local area network (LAN), anintranet, an extranet, a public switched telephone network (PSTN), aninfra-red network, a wireless network (such as that operating withguidelines from an institution like the Institute of Electrical andElectronics (IEEE) 1402.11 suite of protocols, Bluetooth®, and/or anyother wireless protocol), and/or any combination of these and/or othernetworks.

The server 1404 may run a suitable operating system, including any ofoperating systems described throughout herein. The server 1404 may alsorun some server applications, including HTTP (hypertext transportprotocol) servers, FTP (file transfer protocol) servers, CGI (commongateway interface) servers, JAVA® servers, database servers, and/orvariations thereof. A database 1402 may be supported by database serverfeature of a server 1404 provided with front-end capabilities, and thedatabase 1402 enables immutable information storage of informationreceived from a first computing device. In at least one embodiment, suchdatabase server features include those available from Oracle®,Microsoft®, Sybase®, IBM® (International Business Machines), and/orvariations thereof.

As such, a system for immutable virtual pre-site study may include aframe and glasses subsystem that has glasses and/or goggles, and atleast one processor for executing instruction from memory of the system.The subsystem may include a frame, one or more legs pivotally attachedto the frame, one or more detachable lenses coupled to the frame and acamera embedded within or associated with one or more lens of thesubsystem. Further, the system includes an image processor, a storagedevice, a compression module, an image buffer, an image sensor, and asmartphone. Such a smartphone includes a mobile application that isadapted to activate a camera of the subsystem.

In at least one embodiment, a computing device has a virtual sitemonitoring application, one or more processing modules, and one or morenon-transitory storage modules storing computing instructions configuredto run on (or execute on) the one or more processing modules, whichcauses the one or more processing modules to perform activitiesdiscussed with respect to at least FIGS. 4 and 5 . These activitiesinclude opening a session on the application, joining a session on theapplication, accessing a mobile application that is adapted to activatea camera a subsystem, enabling camera access and microphone access onthe application and the smartphone mobile application, transmitting avideo stream or data from the camera to smartphone, and transmitting thevideo stream or data from the smartphone to a computing device that hasthe application and that is remote from the smartphone.

Aspects of system 1400 may be sent from a CRA's location to a researchsite in preparation for an immutable virtual PSSV. For example, eyewearwith an embedded HD camera 1414B and a smartphone 1414A (such as anAndroid® mobile device with the mobile application pre-installed) may besent to the an immutable virtual PSSV to be used by a designated studycoordinator. Further accompaniments, such as customized packaging, andsite visit training materials may also be included.

FIG. 15 illustrates another process flow of a method 1500 for immutablevirtual pre-site study to support clinical trials. Step 1502 of method1500 provides a frame and glasses subsystem in association with at leasta global positioning system (GPS). Step 1504 is for opening a session ina web-based application. The session may be associated with an immutablevirtual pre-site study using a first computing device that is linked tothe session and that is associated with the frame and glasses subsystem.Step 1506 is for enabling location tracking, using the GPS, for alocation of the frame and glasses subsystem during the immutable virtualpre-site study. Step 1508 is for enabling transmission of a script fromthe web-based application to the first computing device. The firstcomputing device is remote from a second computing device thatinterfaces with the web-based application. The interfacing may be bydisplaying a web-based application on a display of the second computingdevice and by receiving input in the second computing device to effectchanges to at least a script within the web-based application or adifferent form application. The script may be associated with a videostream from a camera of the frame and glasses subsystem and with thelocation. The association may occur automatically by target insertionpoints identified for questions in the script.

Step 1510 is for determining if a script is associated with a videostream and with a location. Step 1512 may be performed when this is thecase. Step 1508 may be otherwise repeated. Step 1512 is for displayingthe script with the video stream for the first computing device, whichmay occur when GPS coordinates track to the target insertion points inthe script. The script is to also generate responses from the firstcomputing device, such as by responses provided by a study coordinator aresident of the research site. Step 1514 is for enabling immutableassociation of two or more of locations, time stamps, the video stream,the responses to the script, or a device identifier, in the firstcomputing device. For example, time stamps may be tagged or added to avideo stream to indicate that a location was visited and that responsesto the script are associated with aspects of the location.

In at least one embodiment, an aspect of a location may be an equipmentor an inspection action performed at a location. An inspection actionmay be a measurement of a space, a verification of an equipment, averification of chemicals, cleaners, or other aspects suitable for animmutable virtual PSSV. The immutable association may be to immediatelystore such received information under a read-only feature within a firstcomputing device before such received information is transmitted.Furthermore, a file name may be associated with such receivedinformation and which may not be changed for a lifetime of the receivedinformation. The immutable association may occur within a firstcomputing device but may alternatively occur within a second computingdevice. A report may be generated with similar immutable features fromthe first computing device or the second computing device.

A script for an inspection may include aspects of a screen playgenerated by the form application from the question. The script may beprovided to the first computing device for association with locationdetermined from a GPS during an immutable virtual PSSV and to becoordinated with target insertion points marked in the script. In atleast one embodiment, with the frame and glasses subsystem and the firstcomputing device playing a script at a research site, a studycoordinator has to follow the script and to capture certain information.As such information is captured it may be recorded with time stamps,video stream, responses, and the script, in an immutable manner as aread-only file. Aspects of the script may be changed or overwritten. Forexample, if a further question exists during the an immutable virtualPSSV (such as relating to a refrigerator at the research site),real-time instructions may be provided to instruct a study coordinatoror other person to walk through such a refrigerator unit. Informationobtained may be related to inspection dates, size, and still images. Asa camera may capture a video stream, time stamping and association aportion of the stream to the specific inspection action — of arefrigeration inspection—enables credible record-taking.

The frame and glasses subsystem herein enable real-time capture ofinformation with the script, responses, and time stamps, in an immutablemanner Furthermore, any verbal discussion may be also captured andsynchronized with the video stream and other information gathered. In atleast one embodiment, aspects of linking such information and storage inan immutable manner at a source of such information addresses an issueof credibility—such as, to be able to coordinate informationcommunicated between parties during an immutable virtual PSSV to eachinspection point at a research site, and to do so in an immutable mannerMerely recording actions distinct from a script, responses, or audio,may lack credibility and may be difficult to stitch together after thefact. Further a requirement to provide this from the source at the timeof capture is a technical feature enable by a system and a method of thedetailed description herein.

Furthermore, a study coordinator may be disengaged from the responses toquestions within the script. This enables an element of privacy andremoves bias from the process. Such disengagement may be by capturinginformation in isolation of sentiment that may raise concerns at theresearch site. A study coordinator may only follow along with the scriptand capture information requested in the script. The information isprovided directly to a second computing device of the CRA, withoutcommentary to bias its nature. As a study coordinator may be a staffmember at the research site and not necessarily a third-party, the studycoordinator should not be able to see or alter responses to thequestions laid out in the script. For example, the study coordinator maybe asked to capture and send certain information beforehand, and duringthe an immutable virtual PSSV, but such information may not directlycorrelate to the questions received and may indirectly inform a CRA ofcapabilities at the research site.

While techniques herein may be subject to modifications and alternativeconstructions, these variations are within spirit of present disclosure.As such, certain illustrated embodiments are shown in drawings and havebeen described above in detail, but these are not limiting disclosure tospecific form or forms disclosed; and instead, cover all modifications,alternative constructions, and equivalents falling within spirit andscope of disclosure, as defined in appended claims.

What is claimed is:
 1. A system for an immutable virtual pre-site studyto support clinical trials, the system comprising: a frame and glassessubsystem comprising at least a global positioning system (GPS); and atleast one processor and memory comprising instructions that whenexecuted by the at least one processor cause the system to: open asession in a web-based application, the session associated with theimmutable virtual pre-site study using a first computing device that islinked to the session and that is associated with the frame and glassessubsystem; enable location tracking, using the GPS, for a location ofthe frame and glasses subsystem during the immutable virtual pre-sitestudy; enable transmission of a script from the web-based application tothe first computing device that is remote from a second computing deviceinterfacing with the web-based application, the script to be associatedwith a video stream from a camera of the frame and glasses subsystem andwith the location; enable display of the script with the video streamfor the first computing device, the script to enable responses from thefirst computing device; and enable immutable association of two or moreof locations, time stamps, the video stream, the responses to thescript, or a device identifier, in the first computing device.
 2. Thesystem of claim 1, wherein the memory comprising instructions that whenexecuted by the at least one processor further cause the system to:enable filtering of the video stream for privacy protection of patientinformation.
 3. The system of claim 1, wherein the memory comprisinginstructions that when executed by the at least one processor furthercause the system to: enable transmission of the locations, the timestamps, the video stream, the responses to the script, and the deviceidentifier to the web-based application from the first computing device;and enable immutable storage of the locations, the time stamps, thevideo stream, the responses to the script, and the device identifier. 4.The system of claim 1, wherein the memory comprising instructions thatwhen executed by the at least one processor further cause the system to:associate the script with an audio stream, the audio stream to besynchronized with the video stream and to be provided to a user of thefirst computing device or the second computing device.
 5. The system ofclaim 1, wherein the memory comprising instructions that when executedby the at least one processor further cause the system to: generate areport comprising the locations, the time stamps, the video stream, theresponses to the script, and the device identifier, the report providedfrom the first computing device or from the web-based application on thesecond computing device.
 6. The system of claim 1, wherein the memorycomprising instructions that when executed by the at least one processorfurther cause the system to: enable a first transmission channel betweenthe first computing device and the frame and glasses subsystem totransmit at least the video stream to the first computing device; andenable a second transmission channel between the first computing deviceand the web-based application on the second computing device, the secondcomputing device to enable the transmission of the script for the firstcomputing device.
 7. The system of claim 1, wherein the memorycomprising instructions that when executed by the at least one processorfurther cause the system to: enable a video session between the firstcomputing device and the web-based application on the second computingdevice having an open transmission with the first computing device; andenable overriding the script by an instruction associated with the videosession.
 8. The system of claim 1, wherein the memory comprisinginstructions that when executed by the at least one processor furthercause the system to: enable a text session between the first computingdevice and the web-based application on the second computing devicehaving an open transmission with the first computing device; and enableoverriding the script by an instruction associated with the textsession.
 9. The system of claim 1, wherein the memory comprisinginstructions that when executed by the at least one processor furthercause the system to: enable the session to open in a cloud computingenvironment; associate the first computing device and the secondcomputing device with the session in the cloud computing environment;and control entry of third-parties to participate in the session. 10.The system of claim 1, wherein the memory comprising instructions thatwhen executed by the at least one processor further cause the system to:present the script with the video stream based in part on the locationsbeing associated with inspection actions during the immutable virtualpre-site study; and associate the script with the video stream, thetimestamps, and the location immutably prior to transmission from thefirst computing device to the web-based application.
 11. A method forimmutable virtual pre-site study to support clinical trials, the methodcomprising: providing a frame and glasses subsystem in association withat least a global positioning system (GPS); and opening a session in aweb-based application, the session associated with the immutable virtualpre-site study using a first computing device that is linked to thesession and that is associated with the frame and glasses subsystem;enabling location tracking, using the GPS, for a location of the frameand glasses subsystem during the immutable virtual pre-site study;enabling transmission of a script from the web-based application to thefirst computing device that is remote from a second computing deviceinterfacing with the web-based application, the script to be associatedwith a video stream from a camera of the frame and glasses subsystem andwith the location; displaying the script with the video stream for thefirst computing device, the script to generate responses from the firstcomputing device; and enabling immutable association of two or more oflocations, time stamps, the video stream, the responses to the script,or a device identifier, in the first computing device.
 12. The method ofclaim 11, further comprising: determining patient materials during thevideo stream; and filtering the video stream for privacy protection ofpatient information.
 13. The method of claim 11, further comprising:enabling transmission of the locations, the time stamps, the videostream, the responses to the script, and the device identifier to theweb-based application from the first computing device; and enabling,using a cloud computing environment, immutable storage of the locations,the time stamps, the video stream, the responses to the script, and thedevice identifier.
 14. The method of claim 11, further comprising:synchronizing the script with the video stream and with an audio streambased at least in part on the locations of inspection actions during theimmutable virtual pre-site study; and displaying the script to a user ofthe first computing device or the second computing device.
 15. Themethod of claim 11, further comprising: generating a report comprisingthe locations, the time stamps, the video stream, the responses to thescript, and the device identifier; and providing the report from thefirst computing device or from the web-based application on the secondcomputing device.
 16. The method of claim 11, further comprising:enabling a first transmission channel between the first computing deviceand the frame and glasses subsystem to transmit at least the videostream to the first computing device; and enabling a second transmissionchannel between the first computing device and the web-based applicationon the second computing device, the second computing device to enablethe transmission of the script for the first computing device.
 17. Themethod of claim 11, further comprising: enabling a video session betweenthe first computing device and the web-based application on the secondcomputing device having an open transmission with the first computingdevice; and overriding the script by an instruction associated with thevideo session.
 18. The method of claim 11, further comprising: enablinga text session between the first computing device and the web-basedapplication on the second computing device having an open transmissionwith the first computing device; and overriding the script by aninstruction associated with the text session.
 19. The method of claim11, further comprising: enabling the session to open in a cloudcomputing environment; associating the first computing device and thesecond computing device with the session in the cloud computingenvironment; and controlling entry of third-parties to participate inthe session.
 20. The method of claim 11, further comprising: presentingthe script with the video stream based in part on the locations beingassociated with inspection actions during the immutable virtual pre-sitestudy; and associating the script with the video stream, the timestamps,and the location immutably prior to transmission from the firstcomputing device to the web-based application.